UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060919 |
|---|---|
| Receipt number | R000069698 |
| Scientific Title | Relationship between lower limb loading and muscle activity during stair ascent and descent |
| Date of disclosure of the study information | 2026/05/31 |
| Last modified on | 2026/03/13 11:43:45 |
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Basic information
Public title
Relationship between lower limb loading and muscle activity during stair ascent and descent
Acronym
Relationship between lower limb loading and muscle activity during stair ascent and descent
Scientific Title
Relationship between lower limb loading and muscle activity during stair ascent and descent
Scientific Title:Acronym
Relationship between lower limb loading and muscle activity during stair ascent and descent
Region
| Japan |
Condition
Condition
knee osteoarthritis
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to collect preliminary data on lower-limb loading dynamics and muscle activity during stair negotiation associated with knee joint disorders by measuring forefoot and heel loading patterns and lower-limb muscle activity while healthy participants perform side-facing and backward stair descent.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
This study will include healthy adults with no history of orthopedic disorders. The participants will wear a foot pressure measurement device and will be asked to perform the following tasks: (1) level walking, (2) normal stair ascent, (3) normal stair descent, (4) side-facing stair ascent, (5) side-facing stair descent, and (6) backward stair descent.Foot pressure will be measured using a shoe-type plantar pressure measurement system, the Gait Corder MP-1000 (manufactured by Anima Co., Ltd.). Muscle activity will be recorded using a multi-channel telemetry system, WEB-1000, produced by Nihon Kohden Corporation, and the data will be obtained as numerical values.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Healthy adults with no history of orthopedic disorders will be recruited as participants. The subjects will wear an in-shoe plantar pressure measurement device and will perform the following tasks: (1) level walking, (2) normal stair ascent, (3) normal stair descent, (4) sideways stair ascent, (5) sideways stair descent, and (6) backward stair descent. Electromyographic activity of the lower limb muscles will be recorded using a multi-channel telemetry system .
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 23 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants were students from the Department of Physical Therapy, Faculty of Comprehensive Rehabilitation, and were healthy adults with no history of orthopedic disorders.
Key exclusion criteria
Individuals with no orthopedic disorders.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Iwai |
| Middle name | |
| Last name | Nobuhiko |
Organization
Kobegakuin University
Division name
Faculty of Rehabilitation
Zip code
651-2180
Address
Hyogo,Kobe-shi,Nisiku,Ikawadanicho,Arise
TEL
078-974-1551
iwai@reha.kobegakuin.ac.jp
Public contact
Name of contact person
| 1st name | iwai |
| Middle name | |
| Last name | Nobuhiko |
Organization
Kobegakuin University
Division name
Faculty of Rehabilitation
Zip code
651-2180
Address
Hyogo,Kobe-shi,Nisiku,Ikawadanicho,Arise
TEL
078-1551
Homepage URL
iwai@reha.kobegakuin.ac.jp
Sponsor or person
Institute
Kobegakuin University
Institute
Department
Personal name
Funding Source
Organization
Kobegakuin University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobegakuin University
Address
Hyogo,Kobe-shi,Nisiku,Ikawadanicho,Arise
Tel
078-974-1551
iwai@reha.kobegakuin.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 13 | Day |
Last modified on
| 2026 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069698
